In the next few weeks, Advanced Cell Technologies will file IND with the FDA for retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. If the FDA signs off on ACT's trial, it will be only the second stem cell study to be approved in the U.S. ACT's program will use stem cells to regenerate a certain type of retina cell necessary for vision; it's Phase I/II trial in human would enroll 12 subjects to test the therapy. In animal trials, the company was able to cure blindness in rats.
"We are very pleased with the long-term safety and efficacy data," says Dr. Robert Lanza, ACT's Chief Scientific Officer, in a statement. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."
Geron made news earlier this year when it filed for the first-ever human stem cell trial. That study is currently on hold while the FDA evalutates safety data in animal models.
- see ACT's release
- read the Reuters report